Focetria® pandemic influenza vaccine receives positive European Unionregulatory agency opinion supporting approval

Freitag, 23.02.2007 12:33 von Hugin - Aufrufe: 156

* Approval of Focetria, an immune enhancing pandemic influenza
vaccine, would allow for more rapid response in the event of
influenza pandemic
Basel, February 23, 2007 - Novartis announced today that it has
received a positive opinion supporting European Union regulatory
approval of the human vaccine Focetria® for use in the event of an
pandemic influenza outbreak, such as one that could be caused by the
H5N1 virus.
The Committee for Medicinal Products for Human Use (CHMP), which
reviews applications for all 27 countries in the European Union as
well as Iceland and Norway, has recommended approval of this new
vaccine. The European Commission generally follows the
recommendations of the CHMP and delivers its final decision within
two to three months.
The EU submission for Focetria was considered a "mock-up" since it
lays the groundwork for a more rapid approval and availability of a
specific vaccine once a pandemic has been declared.
Focetria would be manufactured to contain the pandemic influenza
strain declared at the time of a pandemic along with the proprietary
adjuvant MF59 developed by Novartis. Studies have shown that MF59
could boost the body's immune response to the vaccine's active
constituent and extend vaccine supplies by allowing for smaller
amounts of viral antigens to be used in each dose compared to
vaccines without this additive.
"The availability of a pandemic influenza vaccine soon after the
declaration of a pandemic is essential to reduce disease burden and
deaths. This positive recommendation for our proprietary
MF59-adjuvanted pandemic vaccine brings us one step closer to
achieving public health and pandemic preparedness goals," said Dr.
Jörg Reinhardt, CEO of Novartis Vaccines and Diagnostics, a division
of Novartis.
"We are committed to working with governments and international
organizations to reduce the impact of an influenza pandemic through
ongoing research and development projects for pre-pandemic and
pandemic influenza vaccines," Reinhardt said.
Novartis submitted the Focetria mock-up file for EU approval in early
2006. Once the World Health Organization (WHO) declares a pandemic,
Novartis will submit a revised application to the European Medicines
Agency (EMEA) to incorporate the identified viral strain. This
revised application can be approved more quickly than a totally new
application. The filing for the Novartis mock-up vaccine was based on
clinical studies involving the MF59 adjuvant and different H5N1
strains with pandemic potential.
Separately, Novartis has submitted an MF59-adjuvanted H5N1
pre-pandemic influenza vaccine for EU approval based on the same
technology as Focetria. This vaccine is intended for use prior to a
pandemic declaration to help prime and boost the immune system of
those receiving the vaccine to better defend against infections from
a H5N1 virus.
Novartis commitment to pandemic preparedness
Novartis is working closely with government and regulatory officials
worldwide to support pandemic preparedness efforts. Novartis has
engaged in discussions with several governments concerning pandemic
influenza vaccine supply and has provided H5N1 vaccines for
stockpiling, notably in the US and UK.
In January 2007, the US Department of Health and Human Services
awarded Novartis a USD 55 million contract to further develop the
adjuvant technology of MF59 in the US to potentially extend vaccine
supplies in case of a pandemic outbreak.
An adjuvant is a substance added to a vaccine to enhance the body's
immune response to the vaccine's active constituent, called the
antigen. Research supporting the use of the MF59 adjuvant includes:
* Clinical trial data presented at the Second International
Conference on Influenza Vaccines for the World (IVW 2006)
confirming that the addition of the MF59 adjuvant can augment
antibody response and increase protection of subjects against
circulating influenza strains not included in the vaccines
* Clinical research published in The Lancet in 2001 demonstrating
that an MF59-adjuvanted vaccine, based on the non-pathogenic H5N3
virus strain, induced antibodies against H5N1 influenza virus at
lower antigen levels
* A study published in the Journal of Infectious Diseases in 2005
showing that an MF59-adjuvanted vaccine induced broadly
cross-reactive antibodies capable of neutralizing H5N1 viruses
isolated from a number of Southeast Asian countries between 1997
and 2004
* Clinical trial data, supported by the US National Institutes of
Health (NIH), of an MF59-adjuvanted vaccine against an H9N2 avian
influenza virus that were published in 2006 in the online edition
of Clinical Infectious Diseases; in this study, an
MF59-adjuvanted vaccine induced antibody levels believed to offer
protection using one quarter of the dose level used against a
seasonal flu strain
Additionally, Novartis has developed a new vaccine manufacturing
process that uses cell cultures rather than chicken eggs for antigen
production. The new technology may reduce production time to meet
demands of influenza outbreaks and to combat evolving strains of the
virus, including avian influenza strains that are difficult to grow
in eggs. The cell culture-based vaccine Optaflu® was submitted for EU
regulatory approval in July 2006 and is currently in clinical studies
in the US.
About H5N1 avian influenza
Global health authorities have identified H5N1 avian influenza as an
aggressive viral strain with pandemic potential. While researchers
have not quantified the likelihood of an outbreak, to date H5N1 has
caused serious illness in Southeast Asia in more than 250 people. The
mortality rate of patients investigated has been over 50 percent.[1]
An influenza pandemic would be expected to spread quickly globally;
licensing and production of sufficient quantities of pandemic
vaccines is therefore an enormous challenge. The WHO recommends early
vaccine development and use to reduce disease severity and mortality
and stresses the need to work collaboratively with researchers and
manufacturers towards ensuring that as much as possible, vaccines and
antiviral drugs are available at the start of a pandemic[2].
This release contains certain forward-looking statements, relating to
the Novartis Group's business, which can be identified by the use of
forward-looking terminology such as "supporting approval," "would,"
"could", "committed", "will," "can be," "may reduce" or similar
expressions, or by express or implied discussions regarding potential
marketing approvals or future sales of Focetria or other vaccines.
Such statements reflect current views with respect to future events
and are subject to certain risks, uncertainties and assumptions.
There can be no guarantee that Focetria or other vaccines will be
approved for any indications in any market or that Focetria or any
vaccines will reach any particular sales levels. In particular,
management's expectations regarding Focetria and other vaccines could
be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including additional analysis of existing clinical data and
new clinical data; competition in general; the ability of Novartis to
obtain or maintain patent or other proprietary intellectual property
protection; increased government, industry, and general public
pricing pressures; and other risks and factors referred to in the
Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
About Novartis
Novartis Vaccines and Diagnostics is a new division of Novartis
focused on the development of preventive treatments and tools.
Novartis Vaccines is the world's fifth-largest manufacturer and
second-largest supplier of influenza vaccines in the US. The
division's products also include meningococcal, pediatric and travel
vaccines. Chiron, the blood testing and molecular diagnostics
business, is dedicated to preventing the spread of infectious
diseases through the development of novel blood-screening tools that
protect the world's blood supply.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to
discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with
leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2
billion. Approximately USD 5.4 billion was invested in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 101,000 associates and operate in over 140 countries
around the world.
For more information, please visit
# # #
Media contacts
John Gilardi
Novartis Global Media Relations
+41 61 324 3018 (direct)
+41 79 596 1408 (mobile)
Eric Althoff
Novartis Vaccines and Diagnostics Communications
+1-510-387-7604(US mobile)
e-mail: or
Media materials
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products, please visit
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Investor Relations
Ruth Metzler-Arnold +41 61 324 7944
Katharina Ambühl +41 61 324 5316
Nafida Bendali +41 61 324 3514
Jason Hannon +41 61 324 2152
Richard Jarvis +41 61 324 4353
North America
Ronen Tamir +1 212 830 2433
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Edwin Valeriano +1 212 830 2456
[1] WHO Cumulative Number of Confirmed Human Cases of Avian
Influenza, WHO Web site
country/cases_table_2006_10_31/en/index.html, accessed February 6,
[2] WHO Strategic Action Plan for Pandemic Influenza 2006-2007, WHO
influenza/WHO_CDS_EPR_GIP_2006_2c.pdf, accessed February 6, 2007
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